Status:
RECRUITING
The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors
Lead Sponsor:
Arizona State University
Collaborating Sponsors:
Mayo Clinic
Conditions:
Breast Cancer Survivor
Cancer Related Cognitive Difficulties
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.
Detailed Description
The purpose of this innovative, remotely-delivered pilot randomized controlled trial (RCT) is to explore the use of an 8-week prolonged nightly fasting (PNF) intervention, as compared to a Health Educ...
Eligibility Criteria
Inclusion
- ≥18 years old
- diagnosed with breast cancer (all stages included)
- ≥3 months post neoadjuvant or adjuvant chemotherapy (maintenance or palliative systemic therapy is included)
- score ≤30 or lower on the Patient Reported Outcome Measurement Information System Cognitive Function Short Form 8a (sr-CRCI)
- able to speak/understand English
- have access to a computer and Wi-Fi
- live within the United States
- Identifies as female
- willing and able to fully participate in the study
Exclusion
- type 1 diabetes
- actively enrolled in formal diet/weight loss program
- previous bariatric surgery
- eating disorder history
- night shift work
- pregnant, breast feeding, or trying to get pregnant
- dementia, psychological, psychiatric, or neurological diagnoses
- active brain or central nervous system disease
- prior or current use of memory enhancing medications
- history or current brain radiation
- frequently fasting for 12+ hours every night
- 13\) history of hypoglycemia 14) depression screening on PHQ9 with a score of 20 or greater across all 9 questions OR anything other than 0 on question 9
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06938555
Start Date
March 18 2025
End Date
March 20 2026
Last Update
April 22 2025
Active Locations (1)
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1
Arizona State University
Phoenix, Arizona, United States, 85004